Dimerix (ASX:DXB) has announced that recruitment of patients aged 12 to 17 has commenced for the ACTION3 Phase 3 clinical trial in patients with focal segmental glomerulosclerosis (FSGS).
The company said the adolescent-approved dose is the same as the 120mg adult dose currently being administered in the ACTION3 Phase 3 trial, which is given orally and twice daily.
Approximately 15 specialist paediatric nephrology centres across the UK, US, Mexico, Brazil and Argentina have been selected to recruit adolescent patients with FSGS.
The Phase 3 study, which is titled ‘Angiotensin II Type 1 Receptor (AT1R) and Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis’ (ACTION3), is a multi-centre, randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker. Once the ARB dose is stable, patients will be randomly given a placebo or DMX200 (120 mg capsule twice daily).
“The positive recommendation of the IDMC to allow adolescent dosing, further extends the strong safety profile and tolerability of DMX-200 when used in FSGS patients. This is especially important as paediatric FSGS remains an area of high unmet need with limited therapeutic options and a high risk of progression to end-stage kidney disease,” said Dr David Fuller, Dimerix’s chief medical officer.
